tv Key Capitol Hill Hearings CSPAN March 10, 2015 8:00pm-10:01pm EDT
federates to brazil. let us know what you think about the programs you are watching. call us e-mail us or send us a tweet. like us on facebook and follow us on twitter. >> coming up the memorial service for former senator edward brooke. and then the headss of nih testify about medical innovation in the united states followed by a hearing examining the 2016 navy budgets. senator brooke who died on january 3rd was the first african-american lect today the senate by poplar vote. secretary state john kerry,
eleanor holmes martin davis, and the senator's son played tribute to him at the service. from the national cuathedralcathedral. this is an hour. >> and everyone who has lived shall not die forever. as for me i know that he earned this and at the last he will stand upon the earth. after my awakening, he will raise me up and in my body i
shall see god. i myself shall see and my eyes behold him who is my friend and not a stranger. for none of us have life in himself and none become his own master when he dies. for if we have life we are alive in the lord and if we die we die in the lord. so then whether we live or die we are the lord's possession. happy from now on are those who die in the lord. so it is says the spirit for they shall rest from their labors.
>> on behalf of washington cathedral and all who serve it is my privilege to welcome you to the service as we gather to remember and celebrate a life well-lived. washington national cathedral seeks to be a spiritual home for the nation as such it seems so incrediblely fitting and proper that we would gather this morning to remember this great man. this extraordinary public
the lord be with you. >> the lord be with you. >> let us pray. oh god, praise and glory, we remember before you this day our brother edward. we thank you for giving him to us. his family and friends. to know and to love as a companion on our earthly pilgrimage. in your boundless compassion con sole us who morning and give us
faith to see the eternal light so we may continue our course on life until by your call we are reunited with those who have gone before. through jesus christ our lord. amen. >> amen. >> a reading from the prophet isiah: the spirit of the lord is upon me because the lord has anointed me and sent me to send good news the oppressed and bind up the broken heart and proclaim liberty to the captives and to release the prisoners to proclaim the year of the lord and the day of vengeance of our
god. to comfort those who warn and give them a garland instead of ashes ashes. the oil of gladness instead of mourning. the mantle of praise instead of a faint spirit. they will be called the oaks of rightousness. the planting of the lord to display his glory. the word of the lord. >> thanks be to god. >> a reading of the 116th psalm. i love the lord because he heard the voice of my suffocation and
inclined his ear to me whenever i called upon him. the grip of the grave took hold of me. i came to grief and sorrow. then i called upon the name of the lord oh lord i pray to you save my life, gracious is the lord and our god is full of compassion. the lord watches over the innocent. i was brought very low and he helped me. turn again to your rest oh my soul for the lord has treated you well. for you have rescued my life from death. my eyes from tears. and my feet from stumbling. i will walk in the presence of the lord and in the land of the living. i believed even when i said i have been brought very low and
in my distress i said no one can be trusted. how shall i repay the lord for all of the good things he has done for me? i will lift up the cup of salvation and call pawn the name of the lord. i will fufill my vows to the lord in the presence of all of his people. precious is the sight of the lord is the death of his servants. oh, lord, i am your servant. i am your servant and the child of your hand made. you have freed me from my bonds. i will offer you the sacrifice of thanksgiving and call upon the name of the lord. i will fulfill my views to the lord. in the court's of the lord's house in the midst of you oh
brooke family, good morning to all. it is a privilege to share thoughts about edward brooke. i want you to thing about half a century. imagine a room in the 1960s where all of the leading massachusetts politicians are gathered. kennedy, o'neill brooke. among them one figure standards out as the curageious representative of an embattled minority. loathed and undotted and the only episcapalian. imagine another room chamber of the united states senate. on january 10th 1967 a man of
dignity strides down the center aisle and legislatures rise and applaud the gallery &%c0 cheers. the first african-american poplar elected to the senate takes his seat. in that moment edward brooke was not just a pioneer. he was an advanced scout probing the soul of the country. 26 years passed before a second african-american would be elected. imagine a young man raised in washington, joining the army after college and pearl harbborharbor later deploying to italy as part of a segregated battalion. he watches as his buddy were sent to attack a fortified german position every morning.
the young soldier became convinced his men were being used as cannon fire by racist demanders. he proposed a shift in tactics. an operation staged later in the day when the enemy would be sleeping. the answer came back the colonel would never send a boy to do a man's job. brooke persisted. and the operation that he organized finally went ahead catching the enemy by surprise and driving them from the mountain. his battalion suffered 1 300 deaths and won 27 medals. among them a bronze star for ed brooke. his personal was scattered to places where many could neither sit at a lunch counter nor vote. that is where we were back then.
and we must never forget that as much as ike patton, and marshal, edward brooke and the african-americans who joined in fighting facism were part of the greatest eneration and we owe them in uncalculable debt. as a legislature, senator brooke was always on the edge championing a women's right to chose, taking on the tobacco in dusty, initiating a program helping minority business people create jobs guaranteeing women equal access to credit and an amendment that enables tens of thousands of people each year to qualify for public housing and therefore escape shelters or the
streets. edward brooke steered by his own compass, my friends. he had a sense of direction that was defined into the chaos of war. when president nixon after the senate to confirm a supreme court person that argued meadocracy deserved representation fall edward brooke looked the party in the eye and said no and did the same on two other nixon nominees. he also differented from the president by being right about the vietnam war and voting to end it. a position that mattered to a lot of voters in massachusetts including this one. and when they tried to cut civil rights and voting rights laws ed brooke used every instrument
in the legislateive tool bock to stop them. a vow that president obama reminded us so powerfully in selma remains as timely now as ever. for all of his career he was his own man. as attorney general he was relentless on cracking down on corruption which in massachusetts in the early 1960's provided what we might call a target-rich environment. he triumphs were amazing in a state that was 2% black and school desegregation was an issue at the time and where the face of prejudice might appear ugly with anger or thinly masked by code words.
in one race he narrowly lost opponent kevin race claimed to see no hidden message in bumper stickers that read "vote white". he was urged not to run for higher office but instead buy his time until massachusetts was "ready". when he ran for attorney general, elliot richardson was his opponent a man with deep connections to the upper echelons of the commonwealth. edward brooke didn't back down and a straight line can be drawn between his victories and that of another african-american this time in the national arena some four decades later.
i was in high school when edward brooke first ran for state-wide office. attracting so many democratic voters to the republican primary that our party had to work with with months afterwards. i had met ed early in 1971 when where was protesting against the war. but i really didn't know him until i arrived in washington as a senator. in my early years, he would come by and talk about the job or the events of the day. whenever i saw him i was struck by his warmth kindness and in the in what i was doing. he as a genuine laugh, a resident voice, and a ready-willingness to talk to anybody and answer their questions and especially mine. one topic we discussed was the parallels. after all we had both gone
directly from college to war to law school to a prosecutor's office then to spend many years as the junior senator for massachusetts. we had each won and lost elections and guess what? we both agreed that winning is a lot better. believe me few public statements are harder to deliver than a concession speech after a closely contested, even bitter race. in 1978 i will never forget i was struck by how ed's remarks set a new standard for grace amid pain. he said won congrats to opponents to allies he said would carry on this work.
he said when i was down in the valley i didn't cry i tried out and you gave me the strength to move on. early on this proud son introduced me to helen brooke who during my years in the senate embraced me as much as anyone in the city. mother brooke loved her family and her church. she loved to have a good time and taught her son how to be a successful politician. always thank people and make them feel special. that advice stuck. as one colleague observed when edward brooke looked at how you felt he was not only thinking about you and only you but he probably hadn't thought about anybody else in weeks. 15 years ago the court house just across the street from my own district office in boston was named after ed brooke. a tribute to a man and a great
reminder for his love of the law. in massachusetts three charter schools are dedicated to his memory and many of the students made the journey from the land of the seven foot snow drifts to be with us today. and many students from his high school alma mater. senator brooke shunned the title of trailblazer but that is what he was. he inspired thousands of young people of every race to enter public service. some criticized him for not being enough of this or that and trying to mold him into their expectations. but he was always true to himself. he fought with determination for the poor the minorities for women and for what he felt was
right. he valued over substance over rhetoric and public needs over and knew government was us. bipartisan to him was never a four-letter word. so we are privileged to be here. family, friends, admirers, in celebration and thanksgiving for this remarkable man. in recent years as ed brooke received the congressional gold medal and the presidential medal of freedom he reminded us the work to which he did dedicated his own best interest is not finished. ed brooke understood the ebb and
blow of life. he saw triumphs and would be the first to tell us he lived a full and blessed life. for him and for that we will always be grateful. >> and family callolleaguecolleagues, pug public public officials, friends of senator edward william brooke. you did not grow up desiring to be a united state senator if you were born in the district of
columbia in 1919. not if you lived in one of the districts with african-american joyce park. not if you went to a segregated public school. and graduated from dunbar high school and the senator's class of 1936 is in the church today. and from howard university. not even if you became a world war ii hero and won the bronze star leading your segregated unit in broad daylight on an enemy bunker. and certainly not if your hometown had no self elected government, much less senators. edward william brooke was
nurture nurtured in a lovely closely knit aspiring african-american community in the district of columbia. but it did not room him to think of himself has a public official. senator brooke owed much to a childhood spent in our city where children were raised to believe segregation did not for moment mean you were inferior. but the man that became a natural politician charming brilliant, and utterly approachable invented himself and went on to not only become a public official but a historic figure. the senate has always had its share of self made men and women.
edward brookewas a self made senator. many had thought of obama as a man ahead of his time until the president came to the capital in 2009 to present the congressional gold medal to senator brooke. after receiving the medal, senator brooke regaled us remarks that must have been written in his head and his heart because without so much as a note he accepted the medal in a voice that resinated as it must have when he spoke in the senate about the brooke amendment to the fair housing act which limited to 25% the portion of income a family must
pay in rent for public housing. don't ask me how a black man became one of the most poplar politicians ever in massachusetts a state where only 2% of the population was black. i cannot explain the cunonedrum that was edward brooke but i experienced the warmth and the talent that made him successful as a public man and dear as a friend. and i can tell you this edward brooke never forgot where he came from. the city that nurtured his uniqueness. without hesitation he volunteered to talk with
senators in his republican party when the senate and the house both passed the d.c. house voting rights act. he succeeded. the vote for the district was lost to an amendment that would have wiped out all of the district's gun laws in return for a vote in the people's house. senator brook's history was sealed and delivered long before he died in january. his place as the first african-american elected to the senate with the poplar vote and his extraordinary record as a senator are ever n more remarkable when you consider his origins here in the district of
columbia which had no local government at all. the residents of his home town continued to struggle for equal rights as american citizens and for statehood. but nothing could inspire our citizens more than a native sun born in a city without a vote or a local public official who rose to cast votes in the senate of the united states. thank you.
renewed day by day and preparing us for an eternal weight of glory because we look at what cannot be scene. what can be seen is temporary but what cannot be seen is eternal. for we know that if the earthly tent we live in is destroyed we have a building from god. a house not made with hands eternal in the heavens. for in this tent we groan longing to be called with our heavenly dwelling if indeed when we have taken it off we will not be found naked. for while we are still in this
tent we have grown under our burden because we wish not to be swallowed up or to be clothed so that what is mortal maybe be swallowed up by life. he who prepared us for this very thing is god. he has given us this spirit as a guarantee. so we are always confidant even though we know while we are at home in the body we are away from the lord. for we walk by faith. not by sight. yes, we do have confidence. and we would rather be away from the body and at home with the lord so whether we are at home or away we make it our aim to
>> god of justice. save the people from the clash of race and creed. the strife of clad and make our nation free indeed. keep her faith in simple manhood strong as when her life began. till it fine its full fruition in the brotherhood of man. this is a stanza of a favorite hymn of edward william brooke which he often used to close his
speeches as he delivered them across the nation and the world. this stanza summarized his theme of life. his mission in life. long before i ever met him in person i came to know him through the pages of the history of alpha phi paternity. the world's first african-american college african-american paternity founded in 1936. this alpha history book depicted a plethora of role models and heroes. the likes of dubois thur-good
marshal, martin luther king junior and many more whose life inspires and advances a race of people and a nation. none stood out more dramatically than the life and achievements of edward william brooke. he was my hero. dignified, a scholar, charismatic, accomplishments, and fearless. regular history books have yet to give him the credit he has earned.
alpha phi paternity is in its 109th year of existence and for 77 of those 109 years edward william brooke stood in the circle of our brotherhood. when they undertook the 27-year task of building the martin luther king memorial here on the mall in washington, d.c. edward brooke was first to come forward with significant resources and the use of his experience and council to guide that process. he was active an esteemed brother. the law served as his
instrument tool and weapon with which we sought to advance the cause of justice in the face of prejudice, discrimination and segregation which suroundrounded him as he grew up in the nation's capital not far from here. he thought against the tyany of the access powers as a commissioned officer in the united states army during world war ii. assigned to the segregated 366 all-black in fantry rej where he earned a starr on the battlefield.
segregation in dining cars on commerce. black passengers were only allowed to occupy two tables nearest the kitchen. and when occupyied by black travelers a curtain had to be drawn to hide their presence from white passengers. if white passengers needed the table assigned to black passengers the black passengers had to wait until the white passengers had vacated the table assigned to black. edward brooke was recruited to join the alpha legal team headed by then general president of alpha alford lawson in filing briefs that ultimately ended at
the supreme court of the united states. and on june the 5th, 1950 four years before the brown verses the board of education momentous decision. the supreme court of the united states struck down the regulation which allowed segregation and discrimination in railroad dining cars in part because of the heroic efforts of edward brooke. edward brooke was always a champion in the fight against prejudice and discrimination. his standard and measure of a person was a standard of excellence. he only wanted to be judged by the content of his character
rather than his racial back ground. doctor martin luther king who was initiated into the paternity by edward brooke wile king was a graduate student at boston university stated the proposition that life's most persistent and urgent question is what are you doing for others? edward brooke became an ac acknowledge acknowledged national treasure by using his time power, and intellect lifting others up and making sure fair housing voting
right, education, and justice and the promise of equality became more of a practical reality reality rather than just a lofty ideal. in one of his campaigns a boston political writer wrote brooke was a republican in a democratic state, a black in a white state, and prodsent in a catholic state and he is poor. edward brooke replied i pleaded guilty to all indictment and i continue to persevere in my campaign. brooke won. america won. that is what heroes do.
they look reality in the face and persevere. the poet robert lewis stevenson happily sums up my journey of friendship and brotherhood with senator edward w brooke with these words: he has achieved success who has lived well laughed often, and loved much, who has am enjoyed the trust and respect of intelligent men and women and the love of little children who have filled his niche and accomplished his task, who has left the world better
than he found it who has always looked for the best in others and given them the best he had whose life was an inspiration, whose memory was an inspiration. >> on behalf of my family i would like to thank the distinguished speakers who proceeded me for their thoughtful and deeply moving tributes. as they have so eloquently stated and most of you well know my father lived one of the great
american lives. it was my privilege to know him and to be a part of his life. it is my honor to be his son and to be here with all of you today in appreciation of a man whom i love so dearly. the moment of the past are not gone from us nor we from them. the light of each moment shines on through eternity as had light of don't stars travel through space and time to reach our eyes and touch our minds. and so the brilliant light of his great life shines on for us that we may better find our way in the dark unknown. when i was but a child, not too long ago, my father would always
say waste not, want not. usually he would do this as he walked around turning off lights in vacant room or pointing out the unused excess ketchup on my dinner plate. i thought i understood what he meant but when i consider it in the full context of his life it reveals more truth. if he never waste the opportunity to others live a better life none of us wouldcould want for a life that could not be attained. my father constantly strived for a realization of a better world. a world in which the apparent differences between individuals
would never again be mistaken as a cause to deny justice, humanity, dignity, nor used to justify violence exploitation or disrespect. we must continue to work as he did with faith in the possibility of the best imanginable outcome and the asureance that fearfullness cannot mistake the kindness we are capable of. my father was a tender and lovely man and forgave my many errors. he taut me to read speak, to think, to love and be loved. and for all of this and so much
more i am forever grateful. grateful to him and to his mother helen and father edward for raising up a man so entirely and strikingly unafraid to be the best possible version of himself. grateful to the ancestors who surviving hardships and deathalation held intact their vitality of which my father's life was a profound explanation and grateful to my mother whose unconditional love made our lives together so beautiful. we know he will always be with him and pray for him eternal peace.
the senate foreign relations committee examines the president's request for authorization to use force against isis wednesday. secretary of state john kerry, defense secretary ashton carter and joint chiefs chair general martin dempsey will testify. live coverage starts at 9:30 a.m. eastern on c-span.
former secretary of state hillary clinton broke her silence tuesday about the use of her personal e-mail account during her time at the state department. state department spokesperson jen psaki discussed the ongoing review of mrs. clinton. >> that is consistent with what we have been discussing internally. let me just give you a brief update on where we are. we will review the entire 55,000 page set in one batch at the end of that review to ensure that standards are consistently applied throughout the entire 55,000 pages. we expect a review to take several months. obviously that hasn't changed. the release will be posted on a publicly available web site. we will have more information about that hopefully soon. the only documents from that
55,000 pages we will review for separate earlier release are the approximately 300 e-mails all her rape produced to the select committee. this will be reviewed and released prior to the completion of a set of those will be posted and made publicly available. >> in other words even if you haven't filed the foia request you will be able to see the cds and he will put them up publicly so anyone can see them? >> the yeah that will be publicly available. it's just foia standards. we are using foia standards but they will be publicly available. >> i realize it might be hard for 55,000 pages to have an estimate how much time it will take my hand but 300 is seems a little bit easier. >> willits 900 pages in 300 e-mails. shorter than 55,000 by mathematics. i don't have an estimate on that particular piece. i can check and see if there is more specificity. let me add one more thing and
brad asked this last week. specifically reduction criteria has included and would include since we are following the same standards national security personal privacy privilege and trade secrets among others. as per regular process will identify the basis for any reductions and that's i think something that was brought up. >> one last thing. did anyone ask given the alarm of the sticky while asked for an electronic version of it as well? >> i don't believe so mad. i think this has been handled in a specific way for some time. >> later former secretary clinton took questions from reporters about her use of a personal e-mail address. here is some of the exchange from the united nations in new york city. >> there are for things i want the public to know. first, when i got to work as secretary of state i opted for convenience to use my personal
e-mail account which was allowed by the state department because i thought it would be easier to carry just one device for my work and for my personal e-mails instead of two. looking back, it would have been better if i had simply use a second e-mail account and carried a second phone but at the time this didn't seem like an issue. second the vast majority of my work e-mails went to government employees at their government addresses, which meant they were captured and preserved immediately on the system at the state department. third, after i left office the state department asked former secretaries of state for our assistance in providing copies of work related e-mails from our personal accounts. i responded right away and provided all my e-mails that
could possibly be work related which told roughly 35,000 printed pages even though i knew the state department already had the vast majority of them. we went through a thorough process to identify all of my work related e-mails and delivered them to the state department. at the end i chose not to keep my private personal e-mails e-mails about planning chelsea's wedding or my mother's funeral arrangements, condolence notes to friends as well as yoga routines family vacations and the other things you'd typically find in inboxes. no one wants their personal e-mails made public and i think most people understand that and respect their privacy. fourth, i took the unprecedented step of asking that the state department make all my work related e-mails public for
everyone to see. i am very proud of the work that i and my colleagues and our public servants are at the department did during my four years as secretary of state and i look forward to people being able to see that for themselves. [inaudible conversations] >> the city -- senate committee on health labor and pension will
please come to order. we will introduce their witnesses and after the witnesses senators will have five minutes of questions. i have really been looking forward to this day. this is a very important hearing. dr. collins i thank you for coming and dr. hamburg i thank you for coming especially because that caused a change in plans. we don't have to better, to people who know more about what we are talking about than the two of you. this is an opportunity for us to discuss that. let me see if i can put this in some sort of context. this is a busy committee. the last congress senator harkin used to point out that we completed 25 pieces of legislation which became law and senator murray and i were working well together. three major items that we intend to focus on in the next two years among all the others number one fixing no child left
behind and we are working well together toward that and hope to have a markup on that after the recess. second, we are working on simplifying and reauthorizing the federal government supervision of higher education in america. we had a hearing on that recently and an impressive report. senator mikulski, senator burr, senator bennett and i had asked about simplifying regulations so that will be second. but the third topic is to deal with this exciting new era of medicine that we have and take a look at what we can do as a congress working with the president to reduce the cost of the amount of time it takes to go from discovery of a medicine or a treatment or a medical device and take it all the way through to the medicine cabinet or the doctor's office.
now we know important work has been done in congress on that not so long ago. but we have an opportunity this year to make whatever contribution there is to make and it's an area that we have to succeed in because there is not really a political partisanship about this issue. in fact the house of representatives is moving on a parallel track on something they call 21st century cheers. president obama is extremely interested in precision medicine medicine. i attended -- a attended his his announcement that bad interest at the white house recently along with dr. collins and dr. feinberg. i have talked with him about it and was secretary burwell and suffice it to say that i think every member of this committee is interested in identifying what we can do to make it easier to move those drugs, treatments and devices from discovery all
the way through to the medicine cabinet. we are not just talking about moving it to the fda. sometimes it takes two four six, 10 years to get through to the fda's front door so we are not just talking about the fda. we are talking about a whole range of issues there. dr. collins has described it this way. he wrote in 2013 drugs exist for only 250 of the more than 4400 conditions with defined molecular causes. it takes far too long and far too much money to get a new drug into our medicine cabinets. this is no problem cries out for new creative solutions. since dr. collins wrote that the number of conditions with defined molecular causes has increased to more than 5400. a number of new drugs approved has not kept pace with these discoveries. dr. hamburger is here today has said that we are left her lying on the 20th century approaches for the review approval and oversight of achievements and cares of the 21st century.
president obama in his announcement of the new precision medicine and initiative said 21st century business will allow at american research and development. i want the countries that eliminated polio and mapped the human genome to lead a new arab era of medicine one that delivers the right treatment at the right time in some patients with cystic fibrosis this approach is reversed a disease once thought unstoppable. he introduced at the white house announcement the 27-year-old young man whose cystic fibrosis has been cured because it's one of 4% of the sufferers with that disease caused by a mutated gene for which there is now a drug and i think the legislation senator bennett and senator burr worked on may have helped to contribute to that opportunity. so this is a discussion that can affect nearly every american and
which we are going to take very seriously. senator burr and i identified a report, issued a white paper that we have been working on for some time that focus on the issues that we thought the committee ought to identify and we have submitted that to senator murray and the rest of the members of the committee for their consideration. costing too much to bring medical products through the discovery process and development process taking too long whether fda's responsibilities include unrelated activities to what the focus should be the disparity in scientific knowledge of the fda, the fast pace of biomedical and ovation. those are some of the issues that we focused on. what we hope to learn today from two distinguished leaders of our government is exactly what should we be focusing on? we don't want to waste our time. we can do everything so if this train is moving to the station in the next 12 months and if our
goal is to help get from discovery to the medicine cabinet to the doctor's office what are the two or three things that we have to spend our time on? i believe they can do that working together. we are excited about it. it's a chance for your agencies and the rest of the government to let us help you get the obstacles out of the way that might be in the way of your getting your job done. some of them relate to money some don't. some relate just to the pileup of administrative regulations. at our hearing on higher education the chancellor from vanderbilt talked about the fact that he hired a boston consulting group to ask assessed the cost of rules and regulations to operate the university for one year and the answer was $150 million, $11,000 to every student's tuition at the university. so there are a whole range of things. i'm looking forward to this and i thank you dr. collins and
dr. hamburg. i will now turn to senator murray and we will then turn to the witnesses. c thank you very much as chairman alexander, dr. collins and dr. hamburg great to have you both here. have a lot of appreciation for the work you do to improve health and well-being. dr. hamburg as you step down from a roll it fta i especially want to thank you for your many years of service and we are all very grateful for your leadership so thank you very much from all of us. i'm very pleased to be working with chairman alexander and other members of the committee on ways that we can't continue to advance biomedical innovation for patients. i believe we are at a truly fascinating moment in medical innovation right now. we increasingly have the ability to move away from a one-size-fits-all model of treatment and instead treat patients according to their unique characteristics. we have seen enormous growth and life sciences, source of economic strength in job creation. my home state of washington is a great example.
life sciences are the fifth largest employment sector in my state and it's growing. these are good jobs in an industry with global reach and our country needs more of them. it's critical that we secure and build on the united states leadership in medical innovation. to do this i believe congress has to look at how we ramp up investment in a kind of research and development that helps drive this private sector growth. that's something i will be very ingested in exploring as part of our bipartisan efforts in the coming weeks and months. dr. collins i know that you are very concerned about the impact of sequestration and what it has done to nih and ims as well and i hope we can talk about that today as well. i'm eager to hear more about the many efforts at nih to ensure the united states remains the global leader in biomedical research and discovery. the fda drug and device approval process is another topic i know we will receive a lot of focus. dr. hamburg you recently announced that in 2014 the fda
approved 51 new drugs which is the most in almost 20 years. you should be very proud of what that means for patients and families across the country. i look forward to hearing from you today about ways we can build on that. another priority i will be focused on as the needs of women and children in the research development approval process. when we looked at the fda approval process back in 2005 senator kennedy reminded us that when patients open up their medicine cabinet they deserve every assurance that the medicines they take are safe and effective and that is just as true today. so conversations about advancing medical innovation before it will be guided by his vision of hope upholding that assurance. in the weeks and months ahead i hope we can reach an agreement on policies that help get us safe and effective treatments to patients more quickly. i would be good for our economy and could make all the difference for so many families we represent. thank you again to our witnesses for being here today and thank
you chairman alexander for holding this hearing. >> thank you senator murray. we have good attendance already of senators and i would say we have formed a working group of the staff, single working group on the subject for the purpose of identifying how we will proceed. after this hearing in the next few weeks the working group and senator murray and i will sit down and talk about how we can have a bipartisan process taken into account and focus our efforts in a way that gets a result. and that we will be aware of what the house is doing and we will work with secretary burwell and with the president especially on their position medicine initiative. each witness i would ask each of you to summarize at the camp and about 10 minutes or testimonies of the senators will have a chance to have a conversation with you. i thank you both for coming. dr. collins first thank you director of the national institutes of health the largest supporter of biomedical research in the world.
he has been the director of nih since 2009 and he is known for his leadership of the international genome project which led the first completely sequenced human genome in 2003. next we'll hear from dr. hamburg. she is commissioner of the food and drug administration. according to our staff 25 cents of every consumer dollar that is spent in the united states you regulate when you regulate prescription drugs medical devices food and tobacco products. dr. hamburg has been in this role for six years. we are glad she is retiring and i thank her for coming to this hearing because you wanted to have her -- [laughter] >> i don't mean i'm glad she is retiring. [laughter] i will start that one over again. i am glad she is here. and i'm glad she is here because she is retiring and she has this
wealth of knowledge accumulated over the last six years. i especially ask her to come for that purpose because i knew the committee would want to hear from her. dr. hamburg thank you very much for your service to our country and even though you may be retired we hope you will continue to advise us especially during this next year as we work through these issues. i thank senator murray and senator mikulski for keeping me straight on my comments. dr. collins. >> good morning chairman alexander ranking member moran and members of this important committee. it is an honor to appear before you today along side my friend and colleague commissioner peggy hamburg. our agencies have much to gain by working together and we have been doing so and are committed to that effort. in fact paid and i spent a productive three hours just yesterday afternoon along with senior leaders from both of our
agencies who make up the nih fda leadership council discussing a wide range of projects we are working on together. i would like to on behalf of the nih are employees grantees and patient community to thank members of this committee for your continued support and for holding this bipartisan hearing today. i appreciate the opportunity to discuss how we as a nation can derive innovation through federal investments in scientific research. breakthroughs are generated by nih research and i want to show you a few visuals here if you can see the screen. behind many of the gains are country is enjoying health and longevity. for example over the past 60 years deaths from cardiovascular disease have fallen by more than 70%. meanwhile cancer death rates have been dropping 1% annually for the last 20 years. likewise hiv/aids treatments have greatly extended lives and prevention strategies are enabling us to envision the first aids free generation.
today i want to share with you a few of the many promising opportunities for biomedical research innovation. i can assure you the potential of scientific research has never been brighter than it is today. nih remains strongly committed to basic science, fundamental research that serves as the foundation for discoveries and have long made america the world leader in biomedicine and accounts for no less than 145 nobel prizes that have been awarded to our scientists do we support the nih grants and their intramural program. one exciting example in basic science is the brain initiative. this bold multiagency, multiyear effort is enabling development of innovative technologies to provide a clearer more dynamic picture of how individual brain cells and narrow circuits interact in time and space. this initiative will ultimately give us the tools for major advances in brain diseases. from alzheimer's to autism to schizophrenia and traumatic
brain injury. nih is also innovating the translational silence for basic science findings are developed into clinical benefits. let me give you a few examples. recent advances in technology have led to the discovery of more than 1000 risk factors for disease but drug development is a terribly difficult until you're prone business. the major reason for failures as scientists often just don't know how to choose the right pathways to target for the next generation of drugs that they want to develop. so with this in mind we were excited just a year ago to launch the accelerated medicine partnership or amp. this is an unprecedented pre-competitive public-private partnership using cutting-edge scientific approaches to choose the most promising targets for therapeutic intervention. besides nih amp partners include importantly the fda 10 by us --
excited about. is in the near term it will focus on cancer to of accelerate efforts aimed at understanding why cancer does develop a resistance using basic math is with therapeutic responses like biopsies with a combination of therapies targeted to the genetic profile of the wide range of adult and pediatric cancer. a longer-term of the initiative is to launch a national research cohort to play an active role how their genetic information is used to prevent and manager of a broader array of a project of this magnitude will lay the groundwork of novel therapeutics no better time then to embark on this enterprise for this precise personal approach for every day practices.
in a close aide to make this clear with its impact on humans and health allow me to share a story that highlights the early promise of precision madison. when diagnosed with stage three carcinoma of the loan in 2008 it was completely unexpected. 36 years old, never smoked one day in her life. get her tumor was very large. seven centimeters' a very low likelihood of survival beyond one year or two as she recommended the chemotherapy her doctors who were ahead of their time suspected she may have a mutation a mutation of the 33 she was prescribed a drug that blocks the egfr signal after three months of
treatment the tumor shrunk dramatically as you can see followed by surgery to remove the cancerous tissue plus three treatment. today, seven years after diagnosis the doctors can detect no signs of cancer. now she has completed a triathlon landed her dream job as a biology professor and has welcomed a healthy baby girl. the with scientific innovation made from investments to realize that envision has a vast landscape to more precise personalized perches. thank you, mr. chairman we welcome those questions.
>> they give members of the committee i am very pleased to be here today with our shared goal of the innovative treatment the fda looks forward to working with you with the important ever. this will be my last appearance before the committee as i am stepping down but thank you for your support over the years and our constructive engagement with this committee to events fda public health mission and. came to the agency at a time of considerable uncertainty and change in the but it -- biomedical product by the science and technology that my colleagues demanded new models and approaches in turn we took a serious look at our rules to advance by a medical product to ensure we are a gateway not a barrier to the delivery a better and safer and more treatments
and cures. it has been a high priority for me and i am very pleased as the senator noted we approve the most new drugs in 20 years and more or fran drugs than ever before. 41% were first in class products resulting of truly innovative medicines. today we approve drugs faster on average 40 days faster than japan or 70 days and kennedy and -- get a 174 bin europe. and also with medical devices. moreover we have accomplished this wall remaining the gold standard. despite these successes of so with treatments and cures purpose serious public health needs their not being
met and rising expenditures with discovery of new treatments in this context i want to address concerns raised that fda regulation is a principal obstacle to suggest the authority rests be restructured. if you incorrectly diagnosed the condition the treatment is unlikely to work unless we correct -- correctly diagnosed we are likely to find the solution to defer -- deliver those cheers i can give you three examples of misconceptions. , dot that the fda approval lags behind other countries. the reality is starkly different over 75 percent of new drugs approved by a story or e.u. or japan or
canada 2014 through 2013 were approved first by the fda according to a recent report from regulatory science. americans are far more likely to get first access to new businesses whole dash medicine and the number to the fda is rigid and not flexible for approval of the new drug. in fact, the clinical trial requirements have been steadily increasing and flexibility. 45% are based on the surrogate endpoint. 1/3 on the basis of a single clinical trial. we used an expedited approval process last year more than ever before a 66%. thanks to the new authority the you give us, as 74 drugs received the new breakthrough designation.
my final example is investment of biotechnology saying the fda is to blame but biotechnology through 6 billion in terms of dollars invested with leading biotechnology affiliated but one of the two reasons for investment of biotechnology is the improved regulatory climate. i cite these examples to suggest the that that biomedical research is fine but to urge restart with the right diagnosis we don't want solutions based on an accurate diagnosis. i caution those that lower the safety standards over
which americans rely. remember the great leap forward is in part of the high standards of approval that congress put in place after a series of disasters of ineffective medical products. those standards have boosted the confidence that the world places of the biomedical product. together we can build on the progress made in recent years to further advance biomedical science to improve the lives of patients and also i believe we agree can be improved. patients are uniquely positioned for product development they can better meet their needs to capture input to reincorporate in the process.
second more attention needs to be given to buy markers and the surrogate endpoint to identify and target medical treatments as dr. collins was noting. with hundreds of file markers with blood pressure changes but they're still lacking from many diseases like alzheimer's. the biggest obstacle is scientists do not sufficiently understand the causes of alzheimer's and other diseases to identify the target or which patient will benefit from certain drugs. to solve this problem must support public-private partnerships to develop the science that we need for real word it world data needs use in the marketplace. the fda sentinel initiative
is one of the largest use is a big data of health care to prove vital to monitor safety concerns. and it is still in its infancy with real progress with the methodology is needed to harvest of real-world data. eight and also the agency must be able to retain the cutting edge projects and we must work together to retain and higher. but speeding innovation wellhouse maintaining standards supports the patients well as enable the industry to thrive. thank you for your support for the work he will be doing but going forward with the work of all of the of
biomedical research community. >> we will now have around a five minute questions. i have a short run so each of you will have a chance to answer the second question. the national academies have a couple of studies showing investigators time is spent on the task spending $30 billion through nih 80 percent goes into research and who once said 10 percent is a reasonable amount of that would very. so what about that 42 percent for saving money?
and are there things we can do to make that easier? >> investigators are spending 42% of their time instead of directly engage with research as part of the survey shows that number has not changed through 2012. to limit the amount of oversight in to come in from other directions the things that we have done is to standardize the biographical sketch the individuals have to provide while applying for a grant. were held could be offered is a revision how to have
the research that has not gone through revision in 20 years to not currently take account of the risk involved for those ever truly low risk. >> may i interrupt? would you be willing to identify with those are specifically so during the next several months if we could make changes in the lot we could help with that? we don't want to waste our time through next year and recant do everything. so could you say no or submit later what are the one or two or three things? to focus on of with medicines and devices and treatments to the medicine cabinet.
>> i appreciate that question i have a long list i look forward to talking with u.s. greater opportunity. but to name two, one that sounds pedestrian but it is incredibly vexing situation is a rigorous oversight of attendance of scientists that scientific meetings at nih and fda we're spending $50 million with hundreds of employees to go through a process that has relatively little if any added value triggered by misadventures' by other agencies to have conferences in a loss figure is that we pay the price the conference is a critical part to move things forward and very much it is inhibited by the heavy-handed oversight we could benefit from your help. the department of energy
with the scientific budgeting is allowed to carry fun's over into the second year but we are not. coming to the end of september with money to spend if we had the opportunity to carry that over we could be more flexible how we spend the taxpayers' money. >> i agree. specifically are you looking at administrative? >> i want to make sure we don't waste our time so that we get results cause. >> i will go to was slightly higher level to really did needs to levant's the fda activity to support biomedical research. do believe we need to invest more money in regulatory science that enable us to
assess the safety in deficit -- efficacy quality that is under appreciated under invested area of the biomedical product and it is proving to be central as we take the last set of steps from research and development that would make a difference for people's lives and to work with nih in this domain the scientists have the huge amount to contribute to the overall process as well as responsibility for review and for us to ring gauge in a consistent way earlier so that the right studies are
done their return on investment along the way are driving towards a product that works. >>. >> but i want to rescue about the recent outbreak from bacterial infections whether those largest outbreaks with 32 patients infected not causing -- not knowing what caused their death so could you explain how this could have happened ? >> then do what i did -- the water scopes to treat a series that they are in fact, used in more than
500,000 procedures per year in this country usually with great benefit ended allows an approach that is less invasive and has less risks for the health and safety we saw isolated cases of problems of infection and we would investigate those in the are associated with a lapse of the disinfection protocol. in late 2013 relearned of outbreaks involving the antibiotic resistant strain of bacteria where upon investigation it seemed all the procedures for this infection were followed after that began to work
closely with our colleagues so to understand what are the challenges to enable the scope to do its job? so we actively engaged to come up with better strategies to increase the margins of safety. >> could you get to the full fda review? because i am deeply concerned about its image as a reviewer actively engaged. as retry to strengthen the safety for devices for care.
>> on a broader issue as a global leader of biomedical research and innovation reno's sequestration threat is that and it is a week -- a matched from congressman ryan last year. can you say how that was a sequester. >> the 1.$55 billion taken away from our budgets in the middle of the fiscal year resulted in the grants that would have been funded as they were left on the table. we could make up some of that in the subsequent years
but in 2015 we did not recover the entire poem 25 billion that was lost in 2013. for investigators ever already struggling with difficulty to get the grants funded has been significant the over all likelihood with nih to have that supported through inflation has been eroding away to support it. so it puts america at a limited competitive status to see what other countries are doing with the change of a percentage of gdp you can see countries like china and brazil are increasing investment.
whereas we standalone we're losing ground. end of beginning to wonder if there is the future. >> what does that do to you? >> it is like the dark cloud because we stand to lose another $19 billion over the coming years and the consequences are painful to consider. >> stem a kid your testimony to better target of medicines what role does bio marker play in the
therapies? >> i appreciate the question and mentioned the had a three hour meeting yesterday one of the topics was by markers because of the shared interest. but there are a lot of the aisle markers like the blood pressure that we use for cardiovascular disease but of course, we're above to see them develop for like alzheimer's. but this partnership we're doing jointly with industry to make sure all clinical trials reuse the same set of pile markers. maybe it is a blood test or a major protein of the spinal fluid. we would know that to utilize ever therapeutics.
>> with an ihl and fda to participate in the vial mercker consortium. established 2006 comedy by markers has it qualified? >> from patient organizations it is not charged with qualification but for those that need more research to make sure it happens. the fda has doubled to qualify those buying a markers if they reach the standard. >> they have full determination based on the consortium? >> they need to evaluate and the doctor -- dr. hamburg neece to talk about the process if it is but - - big enough to be considered qualified so it is that predictor of what you want
it to predict. >> the qualifications program to develop those in animal models of a few weeks ago your colleague was before the committee as part of the oversight hearing. the studies are not feasible if it is important to for products to finalize that animal rule guidance before this committee as far as i can tell there is no further issue when will that be finalized as required by law? finigan refers begin by thanking all the extraordinary work you have done for prepared this and the development and availability is an aspect
that is key because we do need to develop countermeasures against certain threats where the disease may not exist in nature we would not want to expose people we take the animal will very seriously. but to know that using animal data we could make a good enough assessment of appropriate use of what will be a terrible life threatening disease. we have been working on the animal rules for quite awhile for the research community as well. we did put forward a draft
guidance and comment ended on that august 2014 to have a lot of meetings. it is a priority for great think it is soon probably not before step down and i worked on these issues before i joined the fda but it was a scientific challenge and in fact it has shaped the work is being done it hasn't stopped progress but we will get it done that there is a very important senator waiting for that. >> guy would be remiss if i didn't mention at the same
time about the similar pathways with the final guidance i know what dr. collins said in response to senator murray from sequestration with predictability no consistency you cannot find the things but i will say this dr. hamburg there are lot of companies out there waiting for a pathway readjust approved those and we don't even have a pathway we don't have of final guidance for those manufacturers out there so you have a company but nobody knows how to get there is approved or there is guidance on how to approach yet. is important how we fund
research to have those markers that qualify with the final guidance as they have a final rule is part of a robust response i thank you to both of you. >> solo the spirit of which you had a bipartisan effort with new ideas that not only save lives but create jobs. overall so what -- welcome dr. collins i have a great shot - - story to have the nih in my